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WO2004075825A3 - Dosage forms of amlodipine and processes for their preparation - Google Patents

Dosage forms of amlodipine and processes for their preparation Download PDF

Info

Publication number
WO2004075825A3
WO2004075825A3 PCT/IB2004/000512 IB2004000512W WO2004075825A3 WO 2004075825 A3 WO2004075825 A3 WO 2004075825A3 IB 2004000512 W IB2004000512 W IB 2004000512W WO 2004075825 A3 WO2004075825 A3 WO 2004075825A3
Authority
WO
WIPO (PCT)
Prior art keywords
amlodipine
dosage forms
preparation
processes
solid dosage
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2004/000512
Other languages
French (fr)
Other versions
WO2004075825A2 (en
Inventor
Romi Barat Singh
Nidhi Singh
Vishnubhotla Nagaprasad
Rajiv Malik
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Priority to US10/546,114 priority Critical patent/US20060270715A1/en
Publication of WO2004075825A2 publication Critical patent/WO2004075825A2/en
Publication of WO2004075825A3 publication Critical patent/WO2004075825A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The technical field of the present invention relates to stable solid dosage forms of amlodipine base; and process of preparation thereof. In particular, it relates to solid dosage forms free of dicalcium phosphate. The stable amlodipine solid dosage form includes amlodipine base, microcrystalline cellulose, is substantially free of dicalcium phosphate, and has less than about 0.5% concentration (w/w) of Impurity D after three months at 40°C and 75% relative humidity.
PCT/IB2004/000512 2003-02-28 2004-02-27 Dosage forms of amlodipine and processes for their preparation Ceased WO2004075825A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US10/546,114 US20060270715A1 (en) 2003-02-28 2004-02-27 Dosage forms of amlodipine and processes for their preparation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201/DEL/2003 2003-02-28
IN201DE2003 2003-02-28

Publications (2)

Publication Number Publication Date
WO2004075825A2 WO2004075825A2 (en) 2004-09-10
WO2004075825A3 true WO2004075825A3 (en) 2004-11-11

Family

ID=32922927

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2004/000512 Ceased WO2004075825A2 (en) 2003-02-28 2004-02-27 Dosage forms of amlodipine and processes for their preparation

Country Status (2)

Country Link
US (1) US20060270715A1 (en)
WO (1) WO2004075825A2 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006059217A1 (en) * 2004-12-01 2006-06-08 Ranbaxy Laboratories Limited Stable solid dosage forms of amlodipine besylate and processes for their preparation
EP1833466A1 (en) * 2004-12-28 2007-09-19 Ranbaxy Laboratories Limited Methods for the preparation of stable pharmaceutical solid dosage forms of atorvastatin and amlodipine
NZ561486A (en) 2005-03-15 2011-03-31 Lupin Ltd Pharmaceutical compositions of amlodipine and benazepril
HU230877B1 (en) * 2008-09-30 2018-11-29 EGIS Gyógyszergyár NyR Stable combination medicine
PL236001B1 (en) 2012-12-21 2020-11-30 Adamed Spolka Z Ograniczona Odpowiedzialnoscia Complex pharmaceutical composition comprising candesartan cilexetil and amlodipine, its preparation method and the unit dosage form comprising said composition,
JP2017537944A (en) * 2014-12-12 2017-12-21 アリ ヘルスケア ピーブイティー リミテッドＡｒｉ Ｈｅａｌｔｈｃａｒｅ Ｐｖｔ． Ｌｔｄ． Mouth refresher
US10350171B2 (en) 2017-07-06 2019-07-16 Dexcel Ltd. Celecoxib and amlodipine formulation and method of making the same
CA3265839A1 (en) 2022-09-07 2024-03-14 Lasse KINAST An immediate-release oral pharmaceutical form of amlodipine with increased api content

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4879303A (en) * 1986-04-04 1989-11-07 Pfizer Inc. Pharmaceutically acceptable salts
WO2002053135A1 (en) * 2000-12-29 2002-07-11 Pfizer Limited Amlodipine free base
US20030022922A1 (en) * 2000-12-29 2003-01-30 Lemmens Jacobus M. Amlodipine free base
EP1287826A1 (en) * 2001-08-28 2003-03-05 Pfizer Limited A crystalline form of the free base of Amlodipine
WO2004010976A1 (en) * 2002-07-30 2004-02-05 Whan In Pharm. Co., Ltd Solid dispersion comprising amlodipine, method thereof and pharmaceutical composition comprising the solid dispersion

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10329347B4 (en) * 2003-06-30 2010-08-12 Qimonda Ag Method for wireless data exchange between circuit units within a housing and circuit arrangement for carrying out the method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4879303A (en) * 1986-04-04 1989-11-07 Pfizer Inc. Pharmaceutically acceptable salts
WO2002053135A1 (en) * 2000-12-29 2002-07-11 Pfizer Limited Amlodipine free base
US20030022922A1 (en) * 2000-12-29 2003-01-30 Lemmens Jacobus M. Amlodipine free base
EP1287826A1 (en) * 2001-08-28 2003-03-05 Pfizer Limited A crystalline form of the free base of Amlodipine
WO2004010976A1 (en) * 2002-07-30 2004-02-05 Whan In Pharm. Co., Ltd Solid dispersion comprising amlodipine, method thereof and pharmaceutical composition comprising the solid dispersion

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Week 200412, Derwent World Patents Index; Class B03, AN 2003-302830, XP002293385 *

Also Published As

Publication number Publication date
WO2004075825A2 (en) 2004-09-10
US20060270715A1 (en) 2006-11-30

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